Cleared Traditional

PROPEP DELIVERY DEVICE

K103200 · Rhythmlink International, LLC · General Hospital
Apr 2011
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K103200 is an FDA 510(k) clearance for the PROPEP DELIVERY DEVICE, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Rhythmlink International, LLC (Columbia, US). The FDA issued a Cleared decision on April 12, 2011, 162 days after receiving the submission on November 1, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K103200 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2010
Decision Date April 12, 2011
Days to Decision 162 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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